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TRIAMED, AEROTEC MANU, Fixed wrist hand brace
EUDAMEDClass I (EU MDR)
Ref SRT227M4RModel SRT 200Ref SRT227M3LRef SRT227M3RRef SRT227M1LRef SRT227M2RRef SRT227M4L
Identity
- Trade Name
- TRIAMED, AEROTEC MANU, Fixed wrist hand brace EUDAMED
- Device Name
- UPPER LIMB ORTHOSES EUDAMED
- Model / Reference
- SRT 200 EUDAMEDSRT227M4R EUDAMEDSRT227M3L EUDAMEDSRT227M3R EUDAMEDSRT227M1L EUDAMEDSRT227M2R EUDAMEDSRT227M4L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05944760053911 EUDAMED05944760053942 EUDAMED05944760053935 EUDAMED05944760053867 EUDAMED05944760053881 EUDAMED05944760053904 EUDAMED
- Basic UDI-DI
- 594476005ORTMEMBRULSUPGM EUDAMED
- EMDN Code
- Y060612 WRIST-HAND ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
TRIAMED, AEROTEC MANU, Fixed wrist hand brace by Sc Triamed Srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 594476005ORTMEMBRULSUPGM | Class I | Active |
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Manufacturer
- Manufacturer
- Sc Triamed Srl
- EUDAMED SRN
- RO-MF-000002843
Sources (6)
- EUDAMED e7b87a7a-3f93-4db6-8229-b6a307599327 61 fields · synced Jul 30, 2026
- EUDAMED 3373e363-fef4-43c1-9e7e-3ae865ede351 61 fields · synced May 16, 2026
- EUDAMED 9b0538df-7bfe-4bbe-a678-2ab2ba2e30bf 61 fields · synced May 18, 2026
- EUDAMED faa3acd1-1082-4ffe-9020-d6550e68f56d 61 fields · synced May 18, 2026
- EUDAMED 6bb3a0d6-6d1d-4355-854a-64150ee80fc6 61 fields · synced May 19, 2026
- EUDAMED 94d8640f-f956-423f-a3c5-a72218ecaabc 61 fields · synced May 19, 2026